MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number 866471

Device Problems Device Alarm System (1012); Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2022

Event Type  Injury  

Event Description

It was reported that the customer would like to have a feature that allows them to view all patient alarms in the unit.One situation that occured overnight is that while the nurses were busy with one patient on the floor, another patient on the other end of the hallway was desalting.They did not notice this event.The device was in use on a patient.There was a report of patient harm as the patient was desalting.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The cas reviewed the customer issue with the customer and current workflow.The cas confirms that the philips device is working as specified.The cas is working with the patient to assist them with achieving the desired overview workflow.The customer is requesting additional device functionality, similar to general electric devices previously utilized at their facility.No problem was detected and the device was confirmed to be operating per specifications and no failure was identified.

• Brand Name: INTELLIVUE MX750 PATIENT MONITOR
• Type of Device: INTELLIVUE MX750 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 16016175
• MDR Text Key: 305823395
• Report Number: 9610816-2022-00644
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K210906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention